BEUDAMED
    FDA Recall Terminated

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    Recall: Z-2343-2015 · Initiated July 13, 2015

    Recall

    Recall Number
    Z-2343-2015
    Event Number
    71702
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 13, 2015
    Posted
    August 14, 2015
    Terminated
    March 1, 2017
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    Reason

    The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

    Action

    Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.

    Distribution

    Nationwide Distribution.

    Quantity

    2081